NetScientific PLC (AIM:NSCI)’s portfolio company PDS Biotechnology Corporation (NASDAQ:PDSB) has achieved primary study endpoints in the VERSATILE-002 Phase-2 clinical trial for first-line recurrent or metastatic HPV16-positive head and neck cancer.
The trial, which evaluated the combination of Versamune HPV and KEYTRUDA (pembrolizumab), reported a median overall survival of 30 months in patients, significantly higher than the published results for immune checkpoint inhibitors (ICIs), which range from seven to 18 months.
The overall response rate (ORR) was 34% for patients with a combined positive score (CPS) of ≥1 and 48% for those with a CPS of ≥20.
These figures also surpass the typical ORR for ICIs, which are less than 20% (CPS>1) and less than 25% (CPS≥20).
A Phase-3 registration trial is planned for 2024, focusing on the combination of Versamune HPV, PDS01ADC, and pembrolizumab.
This trial will include a two-part strategy with dose optimisation and a randomised segment targeting overall survival as the primary endpoint.